Director of Analytical Development/Quality Control

Company: Theseus Pharmaceuticals
Location: Cambridge
Posted on: May 22, 2023

Job Description:

Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): "pan-variant" targeted therapies that address all known drug-resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC).
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Role: Director of Analytical Development/Quality Control
Overview:
We are looking for our first Analytical Development professional to join our Technical Operations team. - You will report to the Sr. Vice President of Technical Operations, the Director of Analytical Development/Quality Control (QC) is responsible for overseeing the development, implementation, and execution of analytical methodologies utilized in the development and production of Theseus's clinical assets and building the Analytical/QC function within Theseus to support multiple clinical and commercial programs.
Who are we looking for?

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• You are an energetic and passionate leader who likes to think outside of the box, proactively seeks out learning and is driven by the company's mission of discovering and developing new medications for oncology patients
  
• A highly knowledgeable, flexible, and solution-oriented leader who drives cross-functional results
  
  What are we looking for?
  
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  • A collegial individual who enjoys working in close collaboration with diverse teams
    
  • A willingness to learn new things, adapt to new ways and go with the flow
    
  • A person who thrives in a small company atmosphere and is willing to "roll up their sleeves" to support all activities needed to execute clinical trials
    
  • A person who acts with a sense of urgency and a quality-mindset
    
    What are we offering?
    
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    • Membership within a growing, CARING, and collegial organization
      
    • Being part of passionate, involved, and cutting-edge Discovery Team
      
    • To join a growing team of caring, experienced and motivated individuals focused on making a positive impact in the lives of cancer patients.
      
    • A dynamic work environment that welcomes discussion and adoption of new approaches to improve our Discovery processes.
      
      What you will do:
      
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      • Lead Analytical and QC activities to support the development and manufacturing of drug substance and drug product
        
      • Author and review Quality sections of regulatory submissions and respond to questions from regulatory agencies
        
      • Select appropriate analytical techniques and manage contract partners (CDMOs and/or raw material vendors) to perform analytical method development/validation/transfer
        
      • Critically review release and stability testing results and resolve any OOSs/OOTs
        
      • Demonstrate technical expertise in the development of analytical methods and phase-appropriate control strategies for drug substance and drug product
        
      • Prepare, review, and approve method development and stability program protocols and reports
        
      • Collaborate with cross-functional teams to meet program goals and timelines
        
        What you will bring:
        
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        • Preferably a Ph.D. (minimum MS degree) in analytical chemistry, organic chemistry, or a related discipline
          
        • 10+ years of relevant industrial experience in analytical development, including understanding QC operations
          
        • Experience in the development of small-molecule therapeutic agents in oncology indications
          
        • Excellent scientific and business communication skills (verbal, written, and presentation), strong interpersonal/collaboration skills, and planning skills, as well as people management skills
          
        • Ability to think critically and creatively and be able to work independently to determine appropriate resources for the resolution of problems
          
        • Strong problem-solving skills with sound technically driven decision-making ability
          
        • Ability to multi-task and thrive in a dynamic, fast-paced, and innovative environment
          
        • You have strong written and verbal communication and excellent attention to detail
          
          Our values:
          Transparency: We work with honesty, openness, and integrity.
          Community: We collaborate and thrive together.
          Patient-Focused: We are committed to finding new medicines for patients.
          Resolve: We never give up on our mission.
          When You Join Theseus Pharmaceuticals You Will Have:
          
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          • Location reachable by public transportation (Red Line)
            
          • Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision
            
          • Health Savings Account for medical expenses
            
          • Eligible from the first day for 401K with 100% match of the first 5%
            
          • A robust package of Theseus-paid insurance coverage, including life insurance, short-term and long-term disability
            
          • Unlimited time off and 11 Holidays
            
          • Winter Break: Theseus is closed for a Winter Break between Christmas and New Year
            
            Location: Cambridge (Kendall Square), MA
            Theseus Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
            TO ALL AGENCIES: -Please, no phone calls or emails to any employee of Theseus about our openings. All resumes submitted by search firms/employment agencies to any employee at Theseus via email, the internet or in any form and/or method will be deemed the sole property of Theseus unless such search firms/employment agencies were engaged by Theseus for this position and a valid agreement with Theseus is in place. In the event a candidate who was submitted outside of the Theseus agency engagement process is hired, no fee or payment of any kind will be paid.

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